The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01313819
First received: March 10, 2011
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of gait(FOG)in patients with Parkinson`s disease


Condition Intervention Phase
Parkinson`s Disease
Freezing of Gait
Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of FOGQ score [ Time Frame: 2 days for each drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UPDRS and HY stage [ Time Frame: 2 days for each drug ] [ Designated as safety issue: No ]
  • side effect [ Time Frame: 2 days, 2 weeks after discharge ] [ Designated as safety issue: Yes ]
  • Patient global impression [ Time Frame: 2 days, 2 weeks after discharge ] [ Designated as safety issue: No ]
  • 4*10m walk test [ Time Frame: 2 days for each drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Give IV amantadine first then IV placebo(normal saline) drug
Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication
Active Comparator: Group 2
Give IV placebo drug first then IV amantadine
Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication

Detailed Description:
  1. Freezing of gait (FOG) is one of the most disabling symptoms of Parkinson`s disease.

    We experienced that severe FOG was markedly improved by IV amantadine in the patients who had Parkinson`s disease. But IV drug may have placebo effect. Therefore, We designed double blind, placebo controlled study to know whether IV amantadine is effective in the patient with dopaminergic-drug-resistant freezing of gait(FOG).

  2. Cross over study design

    • Compare the change of FOGQ(freezing of gait questionaire) score from the baseline to IV amantadine and placebo drug
    • randomized assigned order of amantadine and placebo drug.
    • investigator of FOG: blinded to the order of drugs
    • each patient has IV drug for 2 days for each drug
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • age: 30-80 years
  • idiopathic Parkinson's disease
  • The patient must be taking optimised levodopa/DDI therapy (based on investigator's judgement) during OPD observation period, though the patient have FOG-Q score ≥ 10 points even though On-state.

Exclusion Criteria:

  • "Off" freezing:The patient has improved FOG in "On" state
  • clinically significant or unstable medical or surgical condition
  • The patient has Parkinson plus like MSA, PSP, and PPFG, and secondary parkinsonism like NPH, vascular parkinsonism, postencephalitic parkinsonism, CO poisoning.
  • history of seizure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313819

Contacts
Contact: Beom S Jeon, MD, PhD 82-2-2072-2876 brain@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Beom S Jeon, MD, PhD    82-2-2072-2876    brain@snu.ac.kr   
Principal Investigator: Beom S Jeon, MD, PhD         
Sub-Investigator: Young Eun Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01313819     History of Changes
Other Study ID Numbers: H-1012-044-344
Study First Received: March 10, 2011
Last Updated: November 9, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Freezing

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Amantadine
Dopamine
Dopamine Agents
Dopamine Agonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents

ClinicalTrials.gov processed this record on April 17, 2014